|
Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s) Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s) Clinical research trials and Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s) health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s). Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s) Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s) clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s) condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s)  Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s)
Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s)
For Condition: Osteoarthritis, Knee
Status: Recruiting
Sponsor(s): Winston Laboratories ,
Synopsis: The purpose of this study is to evaluate the safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis (OA) of the Knee(s).
Details: This is a 52-week open label study wherein subjects are required to apply the study drug on the knee(s) three times a day. Subjects are required to return to the clinic every 13 weeks. Enrollment Visit (Day 1) At the End-of-Study/Final Visit, Day 84 of Study No. WL-1001-05-01 (or preferably < 30 days following this visit) subjects will be invited to enroll in this long-term open label Study WL-1001-05-04. Subjects will sign a written informed consent prior to being enrolled into the long-term open label study. If enrolled at the final visit or < 30 days after the final visit of Study No. WL-1001-05-01, the final visit physical examination and laboratory examination will serve as baseline for this study. If enrolled > 30 days after the final visit, a new physical examination and laboratory examination will be completed upon enrollment into this study. The subjects will complete an OA Pain Score and Subject Global Evaluation (SGE) for their Target Knee, the same knee designated as the Target Knee in Study No. WL-1001-05-01. A 13-week supply of study drug and subject diaries for the next 13 weeks will be dispensed to each subject. Instructions on how to apply the study drug will be reviewed with the subjects. Subjects will also be instructed to complete their diaries daily (Adverse Events Log and Other Medications Log) and to return their completed diaries and study drug tubes at each clinic visit. Treatment Period (Days 1- 365) Subjects will apply study drug to their Target Knee three times a day for 52 weeks. If the subject’s other knee is affected by osteoarthritis pain, it may be treated with the study drug as well. The study drug tubes will be weighed prior to being dispensed to the subject. Each tube will also be weighed when the subject returns them. At each clinic visit, the study staff will review the diaries with each subject for completeness and legibility. Subjects will complete the OA Pain Score and Subject Global Evaluation at clinic visits on Day 1 and Weeks 13, 26, 39, and 52. Concurrent medications, adverse events, and study drug compliance will be reviewed and recorded by the study staff throughout the Treatment Period at clinic visits on Weeks 13, 26, 39, and 52 (End-of-Study/Final Visit). At the week 52 visit (End-of-Study/Final Visit), a physical examination and laboratory examination will be performed. On Day 365 (End-of-Study/Final Visit) the subject will be discharged after all procedures have been completed.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 40 Years/76 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent. - Subject has participated (and not withdrawn secondary to any adverse event) in the Phase 3 Osteoarthritis Study WL-1001-05-01 and completed End-of-Study/Final Visit preferably < 30 days prior to Day 1 of this study (WL-1001-05-04). - Subject is between 40 and 76 years of age. - Subject is generally in good health. - Subject is expected to be compliant with study procedures. - Female subjects of child-bearing potential must have a negative urine pregnancy test at Day 1. - Female subjects of child-bearing potential agree to use an approved form of contraception and must be on the same contraceptive method and dosage schedule during the entire study. Exclusion Criteria - Presence of tendonitis, bursitis, partial or complete joint replacement of knee(s). - Presence of active skin disease, erythema, infection, wound, or irritation near the treatment area of the knee(s). - Subject has an anticipated need for any surgical or other invasive procedure (e.g., synovial fluid aspiration, arthroscopy, tidal joint irrigation, injectable medications) that will be performed on the knees during the course of the study. - Subject has a history and/or diagnosis of rheumatoid arthritis, fibromyalgia, connective tissue disease, psoriatic arthritis, erosive inflammatory OA, diffuse idiopathic skeletal hyperostosis, severe neurologic or vascular disease. - Subject has active (redness, swelling, fever, etc.) gout or pseudo-gout within 6 months prior to screening. - Subject has Type I or Type II diabetes with peripheral neuropathies. - Subject has had trauma or surgery to the knee(s) within 1 year prior to the Enrollment Period. - Subject has an underlying clinical condition, including previous malignancies that in the Investigator’s judgment, is unstable. - Subject has known allergy or hypersensitivity to capsicum, civamide, or capsaicin-containing products or any constituent of the cream formulation. - Subject has a history of substance abuse within the past 12 months. - Use of certain medications within the given restriction period prior to randomization and during the study.
Total Enrollment: 600
Location and Contact Information:
Rheumatic Disease Associates, Ltd. *Not yet recruiting*
Willow Grove, Pennsylvania, 19090
United States
Not yet recruiting Donna Grezlak 215-657-9977
OMC Clinical Research Center *Not yet recruiting*
Beverly Hills, California, 90211
United States
Not yet recruiting Carol Joseph 310-358-5757
Feinberg School of Medicine/Office of Clinical Rsrch and Trng *Not yet recruiting*
Chicago, Illinois, 60611
United States
Not yet recruiting Lucius Robinson 312-503-1500
University Clinical Research Inc. *Recruiting*
Pembroke Pines, Florida, 33024
United States
Recruiting Susan Rook 954-437-2024
Raleigh Medical Group, PA *Recruiting*
Raleigh, North Carolina, 27609
United States
Recruiting Angie Barefoot 919-782-1806
Summit Research Solutions *Not yet recruiting*
Memphis, Tennessee, 38119
United States
Not yet recruiting Linda Dickson 901-761-5062
Robert W. Levin, MD *Not yet recruiting*
Dunedin, Florida, 34698
United States
Not yet recruiting Laraine Landrosi 727-734-6631
Arthritis Regional Research Center *Recruiting*
Mercerville, New Jersey, 08619
United States
Recruiting Cindy Stanford 609-587-9898
Radiant Research *Recruiting*
Philadelphia, Pennsylvania, 19115
United States
Recruiting Mary Nipp 425-468-6200
Chesapeake Medical Research, LLC *Not yet recruiting*
Baltimore, Maryland, 21239
United States
Not yet recruiting Alice Delaney 410-532-4872
New Mexico Research and Osteoporosis Center, Inc. *Not yet recruiting*
Albuquerque, New Mexico, 87106
United States
Not yet recruiting Phyllis Benavidez 505-855-5505
Clinical Research Center of Reading, LLP *Recruiting*
West Reading, Pennsylvania, 19611
United States
Recruiting Jane Crosby 610-375-2466
University Clinical Research *Not yet recruiting*
Deland, Florida, 32720
United States
Not yet recruiting Angeline Petracca 386-740-0770
Medex Healthcare Research Inc. *Recruiting*
St. Louis, Missouri, 63108
United States
Recruiting Mark Pinson 314-367-0777
NC Arthritis and Allergy Care Center *Not yet recruiting*
Raleigh, North Carolina, 27609
United States
Not yet recruiting Patricia Amend 919-781-9633
Boling Clinical Trials *Not yet recruiting*
Rancho Cucamonga, California, 91730
United States
Not yet recruiting Patricia DesLauriers 909-982-4252
Physicians Research Group *Recruiting*
Indianapolis, Indiana, 46250
United States
Recruiting Brenda Schultz 317-849-5749
Center for Pharmaceutical Research *Recruiting*
Kansas City, Missouri, 64114
United States
Recruiting Teresa Oliver 816-943-0770
Radiant Research *Not yet recruiting*
Boise, Idaho, 83704
United States
Not yet recruiting Mary Nipp 425-468-6200
Piedmont Medical Group *Recruiting*
Winston Salem, North Carolina, 27103
United States
Recruiting Jonathan Helms 336-768-8062
Arthritis and Rheumatic Diseases *Not yet recruiting*
Portsmouth, Virginia, 23701
United States
Not yet recruiting Stephanie White 757-399-5000
University of Arizona *Not yet recruiting*
Tucson, Arizona, 85724
United States
Not yet recruiting Connie Bush 520-626-3608
Radiant Research *Not yet recruiting*
Daytona Beach, Florida, 32114
United States
Not yet recruiting Mary Nipp 425-468-6200
Heartland Research Associates *Not yet recruiting*
Wichita, Kansas, 67207
United States
Not yet recruiting Candace Ratcliff 316-689-6627
Seligman Center for Advanced Therapeutics *Not yet recruiting*
New York City, New York, 10003
United States
Not yet recruiting Angelique Shirky 212-598-6518
Radiant Research *Recruiting*
Greer, South Carolina, 29651
United States
Recruiting Mary Nipp 425-468-6200
Arthritis Clinic *Not yet recruiting*
Racine, Wisconsin, 53402
United States
Not yet recruiting Chris Birchbauer 262-637-1000
Med. Investigations *Recruiting*
Fair Oaks, California, 95628
United States
Recruiting Gaby Zumaran 916-965-3292
Radiant Research *Not yet recruiting*
Atlanta, Georgia, 30342
United States
Not yet recruiting Mary Nipp 425-468-6200
Physicians Pharmaceutical Study Services *Recruiting*
Everett, Washington, 98201
United States
Recruiting Lynn Groomer 425-258-3651
Radiant Research *Not yet recruiting*
Austin, Texas, 78705
United States
Not yet recruiting Mary Nipp 425-468-6200
Innovative Clinical Trials *Not yet recruiting*
Birmingham, Alabama, 35205
United States
Not yet recruiting Geneva Goodwin 205-397-1280
Hightop Medical Research Center *Not yet recruiting*
Cincinnati, Ohio, 45224
United States
Not yet recruiting Kimberly Krogman 513-681-0606
University Hospitals of Cleveland *Recruiting*
Beachwood, Ohio, 44122
United States
Recruiting Michelle Wallette 216-844-6076
Additional Information:
Study ID Numbers: WL-1001-05-04;
Study Start Date: November 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077935
Other Osteoarthritis, Knee Studies:
1. Tidal Lavage in Knee Osteoarthritis
2. Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s)
3. Acupuncture Safety/Efficacy in Knee Osteoarthritis
4. Effects of Strength Training on Knee Osteoarthritis
5. Prevention of Arthritis-Related Work Disability
Related Studies:
Other Osteoarthritis, Knee Clinical Trials
Other Pennsylvania Clinical Trials
Other West Reading Clinical Trials
Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee(s)
|
|
|
|
|
|
|
|
